NCT05907343 Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline
| NCT ID | NCT05907343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2023-05-31 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in cognitively healthy adults and older adults diagnosed with mild cognitive disorder (MCI). The main questions it aims to answer are: * whether it is possible to restore various cognitive functions in older adults diagnosed with MCI by delivering theta burst stimulation (TBS), a form of transcranial magnetic stimulation, and * whether closed-loop TBS is able to induce therapeutic benefits that outperform open-loop TBS. Participants play a cognitive video game while a brain-computer interface (BCI) analyzes their electroencephalogram (EEG) signals and decodes the presence or absence of the contingent negative variation (CNV) potential, a marker of cognitive control. The BCI triggers TBS when its outputs indicate that the participant is not engaged properly in the video game. Researchers will compare the effects of sham, closed-loop, and open-loop TBS using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.
Eligibility Criteria
Inclusion Criteria: * Cognitively normal younger adults 1. Ages between 18 to 35 years 2. Good general health 3. Normal or corrected vision 4. Completed elementary school education or able to understand middle school level experiment instructions * Cognitively normal older adults 1. Ages between 60 to 90 years 2. Good general health 3. Normal or corrected vision 4. Completed elementary school education or able to understand middle school level experiment instructions 5. Score of 23 or higher on the Montreal Cognitive Assessment, a brief formal cognitive screening test, which is used to indicate absence of cognitive impairment * Older adults with mild cognitive impairment (MCI) 1. Ages between 60 to 90 years 2. Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria 3. Good general health 4. Normal or corrected vision 5. Completed elementary school education or able to understand middle school level experiment instructions Exclusion Criteria: 1. Neurological or psychiatric diseases (e.g., personal history of epilepsy/seizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.). 2. Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.) 3. Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.) 4. Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.) 5. Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)
Contact & Investigator
José del R. Millán, PhD
PRINCIPAL INVESTIGATOR
University of Texas at Austin
Frequently Asked Questions
Who can join the NCT05907343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05907343 currently recruiting?
Yes, NCT05907343 is actively recruiting participants. Contact the research team at jose.millan@austin.utexas.edu for enrollment information.
Where is the NCT05907343 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT05907343 clinical trial?
NCT05907343 is sponsored by University of Texas at Austin. The principal investigator is José del R. Millán, PhD at University of Texas at Austin. The trial plans to enroll 180 participants.